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NCT00578903 · ClinicalTrials.gov registry record · Phase 2
Allogeneic Stem Cell Transplant for Patients With Severe Aplastic Anemia
A Phase 2 study, sponsored by Baylor College of Medicine.
- Terminated
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT00578903 is a Phase 2 study that was terminated before completion, run by Baylor College of Medicine. The registered enrollment target is 22 participants.
The verdict
NCT00578903, a Phase 2 study, was terminated before completion, sponsored by Baylor College of Medicine.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
Study Summary
Patients have been diagnosed with severe Aplastic Anemia that have not responded to treatment with immunosuppressive therapy (drugs that suppress the immune system, for example Steroids). The immune system is the system in the body that helps protect the body and fights bacterial, viral and fungal infections. Research studies have shown that patients with Aplastic Anemia have improved survival (may live longer) after receiving a HLA (Human Leukocyte Antigen) identical sibling (brother and sister) stem cell transplants. Patients who do not have matched siblings can undergo immunosuppressive therapy, which has also shown to improve outcome. Unfortunately patients who do not respond to immunosuppressive therapy usually die. The best chance of survival for these patients is an HLA matched unrelated or mismatched related stem cell transplant as described below. Stem cells are created in the bone marrow. They mature into different types of blood cells that people need including red blood cells which carry oxygen around the body, white blood cells which help fight infections, and platelets which help the blood to clot and prevent bleeding. For a matched unrelated stem cell transplant, stem cells are collected from a person (donor) who is not related to the patient but who has the same type of stem cells. For a mismatched related stem cell transplant, stem cells are collected from a donor who is related to the patient and whose stem cells are almost the same as those of the patient but not exactly. The patient then receives high dose chemotherapy. This chemotherapy kills the stem cells in the patient's bone marrow. Stem cells that have been collected from the donor are then given to the patient to replace the stem cells that have been killed. The major problems associated with these types of stem cell transplants are graft rejection (where the patient's immune system rejects the donor stem cells) and severe graft versus host disease (GVHD), where the donors stem cell rea
Interventions
- RADIATION Total Body Irradiation (TBI)
- DRUG Cytoxan
- DRUG Methotrexate
- DRUG Campath
- DRUG FK-506
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2002-02 |
| Est. Completion | 2012-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00578903
The ClinicalTrials.gov registry entry for NCT00578903 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Total Body Irradiation (TBI) is the first listed.
NCT00578903 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00578903 about?
NCT00578903 is a clinical study titled "Allogeneic Stem Cell Transplant for Patients With Severe Aplastic Anemia". Patients have been diagnosed with severe Aplastic Anemia that have not responded to treatment with immunosuppressive therapy (drugs that suppress the immune system, for example Steroids). The immune system is the system in the body that helps protect the body and fights bacterial, viral and fungal i...
What is the current status of trial NCT00578903?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2002-02. Estimated completion is 2012-07.
What interventions are being tested in trial NCT00578903?
The interventions under investigation include: Total Body Irradiation (TBI) (RADIATION), Cytoxan (DRUG), Methotrexate (DRUG), Campath (DRUG), FK-506 (DRUG).
Who is sponsoring clinical trial NCT00578903?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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